The present invention is generally related to systems for sterilizing medical packaging components and, more particularly, is related to a system and method for monitoring and/or controlling the sterilization system.
Large doses of radiation will kill microorganisms. In recent years the medical industry has introduced radiation to sterilize medical products that do not lend themselves to traditional sterilization systems such as those based on heat and steam. Particular interest has focused on sterilization of plastic disposables such as syringes and blood transfusion sets, as well as complex apparatus such as heart-lung machines and kidney dialysis units.
Electron beam irradiation sterilization is one type of radiation-based sterilization system. The quality of sterilization is determined by the dose of radiation applied to the kill zone. The dose is determined by factors such as beam current, electron energy, and beam scanning system parameters. The dose in the kill zone may be estimated by securing dosage meters to areas near the kill zone and correlating the dosage reading with known actual kill rates for the read dosage readings. Alternatively, dosage meters may be applied to the kill zone in preliminary production runs. However, sterilization methods that rely upon reading dosage meters applied to the packaging components throughout the production run are inconvenient and expensive.